The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Assay Kit, Thrombo-screen.
| Device ID | K781880 |
| 510k Number | K781880 |
| Device Name: | ASSAY KIT, THROMBO-SCREEN |
| Classification | Test, Fibrinogen |
| Applicant | PACIFIC HEMOSTASIS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GIS |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-06 |
| Decision Date | 1978-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275000856 | K781880 | 000 |
| 00845275000849 | K781880 | 000 |
| 00845275000627 | K781880 | 000 |
| 00845275000597 | K781880 | 000 |
| 00845275000580 | K781880 | 000 |